| Trial ID: | L0404 |
| Source ID: | IRCT20190122042450N5
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| Associated Drug: |
Pioglitazone
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| Title: |
A Comparison between the Effect of Empagliflozin and Pioglitazon on Echocardiographic Indices in Patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease
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| Acronym: |
--
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| Status: |
Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Condition 1: Nonalcoholic fatty liver disease. Condition 2: Type 2 Diabetes. Condition 3: Cardiomyopathy. <br>Nonalcoholic steatohepatitis (NASH) <br>Type 2 diabetes <br>Cardiomyopathy;K75.81
|
| Interventions: |
Intervention 1: Intervention group 1: Empagliflozin 10 milligram, produced by Dr.Abidi pharmaceutical company, once daily for 6 months. Intervention 2: Intervention group 2: Pioglitazone 30 milligram, once daily, produced by Dr.Abidi pharmaceutical compan
|
| Outcome Measures: |
Echocardiographic Indices. Timepoint: At screening time (visit 1) and 24 weeks after the start of treatment (visit 7). Method of measurement: Echocardiograghy.Weight. Timepoint: At start ,after 12 weeks and 24 weeks. Method of measurement: weight scale.;Body mass index (BMI). Timepoint: At start ,after 12 weeks and 24 weeks. Method of measurement: Calculation with formula.;Liver stiffness measurement (LSM). Timepoint: At start and 24 weeks after intervention. Method of measurement: Liver fibroscan.;Nonalcoholic fatty liver disease fibrosis score. Timepoint: At start and 24 weeks after intervention. Method of measurement: By use of labroatary tests and formula of the NAFLD fibrosis score.;FIB4 index. Timepoint: At start and 24 weeks after intervention. Method of measurement: By use of laboratory tests and formula of the FIB4.;The change of CAP (Controlled attenuation parameter). Timepoint: At start and 24 weeks. Method of measurement: By liver fibroscan.
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| Sponsor/Collaborators: |
Iran University of Medical Sciences
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| Gender: |
All
|
| Age: |
20 yearsno limit
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| Phases: |
Phase 2
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| Enrollment: |
70
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| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be randomized by random blocking method with quadruple blocks and using a random number table of
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| Start Date: |
29/11/2020
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
5 January 2021
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| Locations: |
Iran (Islamic Republic of)
|
| URL: |
http://en.irct.ir/trial/50993
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